MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for STERRAD? 100NX 1-DR STERILIZER 10104 manufactured by Advanced Sterilization Products.
[185667912]
A field service engineer was dispatched to the customer site. The oil mist filter was replaced to resolve the smoke/haze issue. Unit meets specifications and was returned to service. Initial reporter phone #: (b)(6). Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue and system risk analysis (sra). The dhr was reviewed and no issues relating the failure mode were noted. The involved unit met manufacturer specifications at the time of release. The sra shows the risk for exposure to toxic or corrosive material to be "low. " the trending analysis of the smoke/haze issue was reviewed for the previous six months from open date and there was no significant trend. The part was not returned for further evaluation. The assignable cause of the smoke/haze is likely due to the oil mist filter. The field service engineer replaced the part and confirmed the sterrad? 100nx was restored to proper function after service. The issue was resolved at the customer facility. Asp will continue to track and trend this issue. Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185667913]
A customer reported an event of a "smoke" or haze emitting from the sterrad? 100nx sterilizer. There was no report of any injuries or human reactions. An asp field service engineer was dispatched to assess the unit onsite. This event is being reported as a malfunction report subsequent to a serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-00016 |
| MDR Report Key | 9751336 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949453-639 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? 100NX 1-DR STERILIZER |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2020-02-25 |
| Model Number | 10104 |
| Catalog Number | 10104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |